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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K891265
Device Name LATEXCO LATEX EXAMINATION GLOVES
Applicant
Latex Products Co., Inc.
146-148 National Hwy.
Pamplona,Las Pinas
Metro Manilla,  PH
Applicant Contact KONG KUAN
Correspondent
Latex Products Co., Inc.
146-148 National Hwy.
Pamplona,Las Pinas
Metro Manilla,  PH
Correspondent Contact KONG KUAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/08/1989
Decision Date 09/05/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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